March 28th, 2019 by aveciapharma
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is...
Posted in: Pharmaceutical Online
March 20th, 2019 by aveciapharma
By Aryo A. Nikopour, Nitto Avecia Pharma Services Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry,...
Posted in: Outsourced Pharma
February 14th, 2019 by aveciapharma
By Aryo A. Nikopour, Nitto Avecia Pharma Services Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry,...
Posted in: Pharmaceutical Online
January 23rd, 2019 by aveciapharma
By Ming Li, Ph.D., Principle Scientist & Team Lead, Biopharmaceutical Developmental and Aryo A. Nikopour, SVP of Scientific & Technical Services Dr. Ming Li, Principle Scientist and Team Lead in the Biopharmaceutical Developmental department at Nitto Avecia Pharma Services, discusses some basics of...
Posted in: Outsourced Pharma
January 22nd, 2019 by aveciapharma
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it...
Posted in: Pharmaceutical Online
January 17th, 2019 by aveciapharma
Potency of biotherapeutics, often determined by cell-based assays, is one of the most important critical quality attributes. Potency must be monitored throughout the entire drug development cycle as it measures drug activity and provides a direct link to clinical efficacy. An ideal potency assay...
Posted in: Pharmaceutical Online
January 16th, 2019 by aveciapharma
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is important...
Posted in: BioProcess Online, Outsourced Pharma
November 6th, 2018 by aveciapharma
Avecia Pharma's management team returned from a successful week in Cherry Hill, New Jersey, attending the American Pharma Outsourcing Summit 2018. As a special thanks for speaking at the event, we received a donation in Avecia Pharma's honor to UNICEF USA from the event organizers, Generis Group. This...
Posted in: Company News
April 17th, 2018 by aveciapharma
HEADLINE Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies, New Webinar Hosted by Xtalks. SUB-HEADLINE Presentation to highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP and ) and...
Posted in: Press Release
May 17th, 2017 by aveciapharma
It's been a busy month so far at Nitto Avecia Pharma Services! We exhibited at two major industry events, both held in San Diego - the 2017 AAPS National Biotechnology Conference and the 2017 TIDES Oligonucleotide and Peptide Therapeutics Annual Meeting. These events gave us the opportunity to meet with...
Posted in: Company News
April 25th, 2017 by aveciapharma
We will be attending the AAPS National Biotechnology Conference in San Diego from May 1st to May 3rd. This year's main topics for the conference will be: Bioanalysis & Biomarkers, Biosimilars, Emerging Topics, Formulation Development, Drug Delivery & Manufacturing, and Novel Therapeutic Constructs &...
Posted in: Company News